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Agenzia Italiana del Farmaco
Risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension (clobazam) - Risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension (clobazam)
Risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension (clobazam)
Epaclob 1mg/ml and 2mg/ml oral suspensions are not bioequivalent to clobazam tablets and care should be taken when prescribing these medications. When taking Epaclob Oral Suspension, clobazam reaches higher plasma levels than the same dose as a tablet.
This may lead to an increased risk of respiratory depression and sedation, which may be most noticeable when switching to this medicine from tablets.
Published on: 17 December 2020
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